Scientists at work: IUB geneticists

In his recent book Next, Michael Crichton addresses the issues of genetic engineering. He provides accurate information and insightful comments on stem cell research, patenting of the human genome, gene therapy, transgenic animals, common public misconceptions and university research. Mixed with the data, however, is a good amount of fiction, and sometimes it becomes difficult to separate the two. Indiana University has a strong genetics faculty who shed light on the science and issues raised by Crichton.

One of the most controversial topics in the world of science today is stem cell research. Adult stem cells are found throughout the body and generate new tissues, but are limited in the type of cells they can produce; a liver stem cell can only make other liver cells.

Embryonic stem cells, however, can develop into any kind of tissue. But research on embryonic stem cells ultimately destroys an embryo, sparking heated debates.

But research is promising. Techniques are being developed that can convert adult cells to embryonic stem cells. Indiana University Bloomington Professor of Genetics Jose Bonner describes the process.

"Take one of my cells, say a skin cell, and fuse it with an unfertilized egg from which the nucleus has been removed," Bonner says. "This reprograms the genes of the skin cell nucleus, and creates a fertilized egg with my DNA. We let that cell divide a few times, creating a very early-stage embryo. Then we take the totipotent stem cells (capable of developing into any cell type), and treat them 'just so' to cause them to develop into kidneys. Now we have kidneys that are appropriate for my body."

Right now, however, scientists don't know how to treat the stem cells to cause them to develop into kidneys. Finding out requires research that disrupts embryo development.

The Human Genome and Patenting

Crichton's main story line is based on the case of John Moore who was diagnosed and treated for hairy cell leukemia at the medical center of UCLA. Over the next seven years, Moore returned numerous times and was told these visits were essential to his health, when in fact the samples were being used to create a new cell line to fight cancer.

The California Supreme Court ruled that Moore had no property rights to his cells once they left his body, though the physician, Dr. David Golde, should have expressed his financial interest in his cells.

Though Golde patented the cell line without Moore's permission, and sold it to Sandoz Laboratories, with stocks currently worth about $5 million dollars, Moore was only awarded a small amount of money.

"Moore's cells have sparked a long debate," says IUB Professor of Genetics Milton Taylor. "The cell line is decades old and no compensation was given to the man the cells came from. So who gets the reward? The person? The researcher?"

Similarly, many companies and universities hold patents on the human genome. There are 35,000 genes in the human genome, and more than 20 percent are privately owned, with more than 4,000 DNA-based patents being granted each year. Should companies and universities be allowed to patent the human genome in hopes of securing rights to products derived from specific genes?

"Patents stop research in one sense and promotes it in another," Taylor says. "Without patents, most companies would not be interested in doing the research. And companies can modify genes or gene products as one way to get around patents. Interferon is a good example." Bonner agrees with Taylor, adding, "I find it completely wacky that genomes can be patented. They already exist. Everyone has one. It's like trying to patent Indiana because you discovered it first."

Gene Therapy

One of the most promising medical practices currently under research is gene therapy.

According to Taylor, gene therapy has been relatively successful on people with combined immunodeficiency. This disease cripples immune systems and is the cause for many children living inside of a "bubble."

Gene therapy takes the DNA a doctor wishes to change and integrates it into the genome of an otherwise harmless virus. The virus is then grown in cells taken from the patient, usually lymphocytes (a type of immune cell), in the case of combined immunodeficiency. The virus DNA, along with the foreign DNA passenger, integrate into the cell's chromosomes, and the genetically-modified cells are then injected back into the patient's bone marrow. The technique can be successful, but it can also cause unexpected and deadly problems.

"The delivery device used [for the children with combined immunodeficiency] was a mouse virus that is not harmful to humans," Taylor explains. "But it turned out that when the virus was integrated into the chromosome, it gave some of the patients leukemia. So was the treatment really successful?"

Taylor and Bonner agree that there is still a lot of potential for gene therapy, but stories such as these remind us of how little we still know.

The Bayh-Dole Act

At the end of his book, Crichton calls for a repeal of the Bayh-Dole Act of 1980. This is the law that allows universities to patent, license and profit from their research. He argues that publicly funded universities profit from publicly funded research and create products that the public then has to pay for.

But the Bayh-Dole Act has been one of the primary reasons for the explosion in university research over the past 25 years.

"The Bayh-Dole Act of 1980 has certainly accelerated technology transfer from universities and government laboratories while changing the economic partnership between government, academia and industry," says IU President-Elect Michael McRobbie. "The Act provides an incentive for talented researchers with bold ideas to profit from commercializing their inventions. In turn, technology transfer in the form of licensing, royalty fees or company start-ups generate critical resources for universities while stimulating the local and national economies."

According to a 1999 Council on Governmental Relations report, the number of universities actively engaging in patenting research has jumped to more than 10 times the number in 1980, when the Bayh-Dole Act was passed. Today, 250,000 jobs and $30 billion can be traced to technologies from universities.